December 2016 FDA Recall Finasteride by Hetero Drugs Ltd. - Unit 1
D-0453-2017 - Failed Tablet/Capsule Specification
This Class III drug recall was voluntarily initiated by Hetero Drugs Ltd. - Unit 1 on December 29, 2016 for the product Finasteride. The FDA reported the reason for recall as failed tablet/capsule specification. The product was distributed in NJ only. and the recall is currently terminated.
Recall Number: D-0453-2017
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
12-29-2016
02-08-2017
20,412 units
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hetero Drugs Ltd. - Unit 1
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NJ only.
07-11-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Batch or Lot Expiration Information
Lot# : FIN16002, Exp. 03/2018
